Primary Prevention of Gastric Varices Bleed

Endoscopic Ultrasound Clinical Trial

Official title: EUS-guided Therapy vs Non-selective Beta Blocker for the Primary Prophylaxis of Gastric Varices Bleed: a Randomized Controlled Trial

Status Withdrawn

Clinical Trial Summary

Primary prophylaxis of gastric varices is an important area of research, as gastric varices are a common complication of cirrhosis of the liver. Cirrhosis is a condition in which the liver becomes scarred and loses its ability to function properly, and it is a leading cause of morbidity and mortality worldwide. Gastric varices occur in up to 30% of patients with cirrhosis, and they can rupture, leading to life-threatening bleeding. The clinical, epidemiological, and public health context of primary prophylaxis of gastric varices is therefore the need to prevent the development of this complication in patients at risk for cirrhosis and to reduce the associated morbidity and mortality. The clinical trials on primary prophylaxis of gastric varices are therefore focused on evaluating the safety and efficacy of various interventions, such as beta-blockers and endoscopic techniques, in reducing the risk of gastric varices in patients with cirrhosis. The goal of this trial is to find the most effective and safe strategies for primary prophylaxis of gastric varices, in order to improve the outcomes for patients with cirrhosis.

Clinical Trial Description

Primary gastric varices (GV) are a condition that affects 17% of patients with liver cirrhosis who have not previously received treatment, either endoscopic or pharmacologic. Although the incidence of GV is lower than oesophageal varices (EV) and the bleeding rate is also less frequent, GV bleeding is more severe and is associated with higher re-bleeding and death rates when compared to EV. The management of acute GV bleeding is well established, but the primary prophylaxis (PP) for certain types of GV remains unclear. The management of GOV-1 (gastroesophageal varices type 1) is recommended as for EV, but for isolated gastric varices type 1 (IGV-1) and gastroesophageal varices type 2 (GOV-2), PP is not clearly defined. Existing guidelines from the American Association for the Study of Liver Diseases (AASLD) and the European Association for the Study of the Liver (EASL) do not provide strong recommendations for primary prophylaxis of IGV-1/GOV-2. While EASL suggests the use of nonselective beta-blockers (NSBB) for IGV-1/ GOV-2 based on one Randomized Controlled Trial (RCT) from 2011 on 89 patients, comparing NSBB vs. endoscopic glue injection for primary prophylaxis in GOV-2/IGV-1. The Baveno consensus VII recommends NSBB in PP but emphasizes the need for further studies. However, no study compares NSBB vs. EUS-GV management in primary prophylaxis. Establishing primary prophylaxis for IGV-1/GOV-2 is even more important as the 2-year incidence of variceal bleeding from IGV1 and GOV-2 type of varices is more frequent and profuse (78% and 54%, respectively) than the lesser curve (GOV-1) varices (28%).

Clinical research has shown that the use of non-selective beta-blockers, such as propranolol and nadolol, can be effective in reducing the risk of developing gastric varices in patients with cirrhosis. These medications work by reducing blood flow to the dilated veins in the stomach, thereby reducing the pressure in these vessels. In addition to the use of beta-blockers, there have been other interventions studied for primary prophylaxis of gastric varices. These include the use of endoscopic techniques such as band ligation and injection sclerotherapy, and the use of the cyanoacrylate glue. ;

Related Conditions & MeSH terms

• Endoscopic Ultrasound
• Esophageal and Gastric Varices
• Gastric Varices Bleeding
• Varicose Veins

• NCT number: NCT05859009
• Study type: Interventional
• Source: Unity Health Toronto
• Status: Withdrawn
• Phase: N/A
• Start date: July 1, 2023
• Completion date: July 1, 2026